Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000101482
Ethics application status
Approved
Date submitted
30/01/2007
Date registered
31/01/2007
Date last updated
31/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of progressive resistance strength training for people with multiple sclerosis who have difficulty walking
Scientific title
The effects of a community based progressive resistance strength training program on the walking performance of adults with multiple sclerosis who have mild to moderate difficulties walking
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 1595 0
Condition category
Condition code
Neurological 1698 1698 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community gymnasium based progressive resistance strength training (PRST) program. Participants allocated to the experimental group will complete a 12-week (two times per week, for 90 minutes per session), gymnasium-based strengthening program targeting the major muscle groups of the legs.
Intervention code [1] 1580 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group will receive 'usual care plus a social program'. The 'usual care' in the control group may include normal exercise, or therapy, providing it does not include a PRST component. In addition, these people will receive an alternative program of educational and social activities designed to be of interest and of value to the participants. This program will be conducted one-hour each week for 12 weeks to control for the social aspect of the PRST program. The program will comprise leisure and recreational activities that would not be expected to have a fitness or training effect, such as massage, film going, visits to leisure and recreational attractions around Melbourne, luncheons and other social activities.
Control group
Active

Outcomes
Primary outcome [1] 2354 0
Fast walking speed over 10m.
Timepoint [1] 2354 0
All outcome measurements will be taken three times: at baseline, after twelve weeks, and after a further twelve weeks (week 24).
Primary outcome [2] 2355 0
Walking endurance.
Timepoint [2] 2355 0
All outcome measurements will be taken three times: at baseline, after twelve weeks, and after a further twelve weeks (week 24).
Secondary outcome [1] 4107 0
1. Fatigue will be assessed using the Modified Fatigue Impact Sale (MFIS)
Timepoint [1] 4107 0
People in the experimental and the control groups will have all outcome measurements taken three times: at baseline, after twelve weeks, and after a further twelve weeks (week 24).
Secondary outcome [2] 4108 0
2. Health-related quality of life will be quantified using the WHOQoL-Br?f scale
Timepoint [2] 4108 0
People in the experimental and the control groups will have all outcome measurements taken three times: at baseline, after twelve weeks, and after a further twelve weeks (week 24).
Secondary outcome [3] 4109 0
3. Self-efficacy will be measured using the Multiple Sclerosis Self-Efficacy scale
Timepoint [3] 4109 0
People in the experimental and the control groups will have all outcome measurements taken three times: at baseline, after twelve weeks, and after a further twelve weeks (week 24).
Secondary outcome [4] 4110 0
4. Maximal Force generation and muscle endurance.
Timepoint [4] 4110 0
People in the experimental and the control groups will have all outcome measurements taken three times: at baseline, after twelve weeks, and after a further twelve weeks (week 24).

Eligibility
Key inclusion criteria
1.Diagnosed with MS 2.have a Hauser Ambulation Index score of 2-4 (mild to moderately severe gait disability) 3.have received a medical clearance to participate in the exercise program.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:1.an acute exacerbation of MS within two months of starting the program 2.presence of an unstable medical condition such as inadequately controlled diabetes or high blood pressure 3.the presence of any concurrent neurological condition, for example stroke 4.MS of the benign or progressive/relapsing types 5.participation in a strength training program in the six months prior to the start of the study.We will recruit both male and female participants.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed sequentially numbered opaque envelopes administered by the research coordinator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block allocation sequence will be generated using a random-number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors and data analyst will be blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment outside Australia
Country [1] 477 0
New Zealand
State/province [1] 477 0

Funding & Sponsors
Funding source category [1] 1841 0
Charities/Societies/Foundations
Name [1] 1841 0
Multiple sclerosis (MS) Research Australia
Country [1] 1841 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 1659 0
Charities/Societies/Foundations
Name [1] 1659 0
Multiple Sclerosis (MS) Society
Address [1] 1659 0
Country [1] 1659 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3443 0
La Trobe University.
Ethics committee address [1] 3443 0
Ethics committee country [1] 3443 0
Australia
Date submitted for ethics approval [1] 3443 0
Approval date [1] 3443 0
23/01/2007
Ethics approval number [1] 3443 0
06/96

Summary
Brief summary
Muscle weakness is common in people with multiple sclerosis (MS), and this can affect the performance of many everyday activities such as walking. A pilot study we completed showed that for people with MS weight training can lead to increased strength, improved walking ability, and improved physical functioning. Perhaps even more importantly, people in the pilot study overwhelmingly reported that they enjoyed the program because it made them feel more energetic, less disabled and more confident. This study will be the first large scientifically rigorous trial of a gymnasium-based strength training program for people with MS in the world.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27514 0
Address 27514 0
Country 27514 0
Phone 27514 0
Fax 27514 0
Email 27514 0
Contact person for public queries
Name 10769 0
Professor Karen Dodd
Address 10769 0
School of Physiotherapy, La Trobe University
VIC 3086
Country 10769 0
Australia
Phone 10769 0
+61 3 94795793
Fax 10769 0
+61 3 94791946
Email 10769 0
k.dodd@latrobe.edu.au
Contact person for scientific queries
Name 1697 0
Professor Karen Dodd
Address 1697 0
School of Physiotherapy, La Trobe University
VIC 3086
Country 1697 0
Australia
Phone 1697 0
+61 3 94795793
Fax 1697 0
+61 3 94791946
Email 1697 0
k.dodd@latrobe.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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